Brimonidine Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials evaluate brimonidine across various ophthalmic and dermatological conditions. Early Phase 1 and Phase 1 studies investigate monotherapy or combination regimens targeting presbyopia, pseudophakia, glaucoma, ocular hypertension, and other eye diseases, while a Phase 4 clinical trial assesses its use in managing facial telangiectasias and associated erythema. Sponsored by academic medical centers and pharmaceutical organizations, these studies are listed as completed or of unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05006898	Completed	Presbyopia	Optall Vision	2020-06-01	Phase 1
NCT03825081	Unknown status	Presbyopia\|Pseudophakia	Massachusetts Eye and Ear Infirmary	2019-01-21	Early Phase 1
NCT02967614	Completed	Glaucoma\|Eye Diseases\|Ocular Hypertension	Kukje Pharma	2016-12	Phase 1
NCT02761174	Completed	Telangiectasias	Merete Haedersdal\|Skinperium Christine Dierickx\|Ellipse A/S Agern Allé 11 2970 Hørsholm\|Bispebjerg Hospital	2016-03-13	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Brimonidine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brimonidine selectively binds to and activates alpha-2 adrenergic receptors, which suppresses adenylyl cyclase activity and lowers intracellular cyclic adenosine monophosphate levels. This signaling cascade decreases aqueous humor production while increasing uveoscleral outflow, effectively reducing intraocular pressure in glaucoma and ocular hypertension, while also inducing peripheral vasoconstriction relevant to managing facial telangiectasias.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).